Article: Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial

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TitleCombination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial
AuthorsChan, FKL2
Wong, VWS2
Suen, BY2
Wu, JCY2
Ching, JYL2
Hung, LCT2
Hui, AJ2
Leung, VKS1
Lee, VWY2
Lai, LH2
Wong, GLH2
Chow, DKL2
To, KF2
Leung, WK2
Chiu, PWY2
Lee, YT2
Lau, JYW2
Chan, HLY2
Ng, EKW2
Sung, JJY2
Issue Date2007
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
CitationLancet, 2007, v. 369 n. 9573, p. 1621-1626 [How to Cite?]
DOI: http://dx.doi.org/10.1016/S0140-6736(07)60749-1
AbstractBackground: Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding. Methods: 441 consecutively presenting patients who were taking non-selective NSAIDs for arthritis were recruited to our single-centre, prospective, randomised, double-blind trial after admission to hospital with upper-gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients were given 200 mg celecoxib twice daily. 137 patients were randomly assigned to receive 20 mg esomeprazole twice daily (combined-treatment group), and 136 to receive a placebo (control group) for 12 months. The primary endpoint was recurrent ulcer bleeding during treatment or within 1 month of the end of treatment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00365313. Findings: Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8·9%) in the controls (95% CI difference, 4·1 to 13·7; p=0·0004). The median follow-up was 13 months (range 0·4-13·0). Discontinuation of treatment and the incidence of adverse events were similar in the two treatment groups. Interpretation: Patients at very high risk for recurrent ulcer bleeding who need anti-inflammatory analgesics should receive combination treatment with a COX 2 inhibitor and a PPI. Our findings should encourage guideline committees to review their recommendations for patients at very high risk of recurrent ulcer bleeding. © 2007 Elsevier Ltd. All rights reserved.
ISSN0140-6736
2011 Impact Factor: 38.278
2011 SCImago Journal Rankings: 1.486
DOIhttp://dx.doi.org/10.1016/S0140-6736(07)60749-1
ReferencesReferences in Scopus
DC Field
Value
dc.contributor.authorChan, FKL
dc.contributor.authorWong, VWS
dc.contributor.authorSuen, BY
dc.contributor.authorWu, JCY
dc.contributor.authorChing, JYL
dc.contributor.authorHung, LCT
dc.contributor.authorHui, AJ
dc.contributor.authorLeung, VKS
dc.contributor.authorLee, VWY
dc.contributor.authorLai, LH
dc.contributor.authorWong, GLH
dc.contributor.authorChow, DKL
dc.contributor.authorTo, KF
dc.contributor.authorLeung, WK
dc.contributor.authorChiu, PWY
dc.contributor.authorLee, YT
dc.contributor.authorLau, JYW
dc.contributor.authorChan, HLY
dc.contributor.authorNg, EKW
dc.contributor.authorSung, JJY
dc.date.accessioned2012-09-05T05:27:19Z
dc.date.available2012-09-05T05:27:19Z
dc.date.issued2007
dc.description.abstractBackground: Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding. Methods: 441 consecutively presenting patients who were taking non-selective NSAIDs for arthritis were recruited to our single-centre, prospective, randomised, double-blind trial after admission to hospital with upper-gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients were given 200 mg celecoxib twice daily. 137 patients were randomly assigned to receive 20 mg esomeprazole twice daily (combined-treatment group), and 136 to receive a placebo (control group) for 12 months. The primary endpoint was recurrent ulcer bleeding during treatment or within 1 month of the end of treatment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00365313. Findings: Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8·9%) in the controls (95% CI difference, 4·1 to 13·7; p=0·0004). The median follow-up was 13 months (range 0·4-13·0). Discontinuation of treatment and the incidence of adverse events were similar in the two treatment groups. Interpretation: Patients at very high risk for recurrent ulcer bleeding who need anti-inflammatory analgesics should receive combination treatment with a COX 2 inhibitor and a PPI. Our findings should encourage guideline committees to review their recommendations for patients at very high risk of recurrent ulcer bleeding. © 2007 Elsevier Ltd. All rights reserved.
dc.description.natureLink_to_subscribed_fulltext
dc.identifier.citationLancet, 2007, v. 369 n. 9573, p. 1621-1626 [How to Cite?]
DOI: http://dx.doi.org/10.1016/S0140-6736(07)60749-1
dc.identifier.doihttp://dx.doi.org/10.1016/S0140-6736(07)60749-1
dc.identifier.epage1626
dc.identifier.issn0140-6736
2011 Impact Factor: 38.278
2011 SCImago Journal Rankings: 1.486
dc.identifier.issue9573
dc.identifier.pmid17499604
dc.identifier.scopuseid_2-s2.0-34248216918
dc.identifier.spage1621
dc.identifier.urihttp://hdl.handle.net/10722/163078
dc.identifier.volume369
dc.languageeng
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
dc.publisher.placeUnited Kingdom
dc.relation.ispartofLancet
dc.relation.referencesReferences in Scopus
dc.subject.meshAged
dc.subject.meshAnti-Inflammatory Agents, Non-Steroidal - Adverse Effects - Therapeutic Use
dc.subject.meshAnti-Ulcer Agents - Adverse Effects - Therapeutic Use
dc.subject.meshCyclooxygenase Inhibitors - Adverse Effects - Therapeutic Use
dc.subject.meshDouble-Blind Method
dc.subject.meshDrug Therapy, Combination
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshMale
dc.subject.meshOmeprazole - Adverse Effects - Therapeutic Use
dc.subject.meshOsteoarthritis - Drug Therapy
dc.subject.meshPeptic Ulcer Hemorrhage - Chemically Induced - Prevention & Control - Therapy
dc.subject.meshProton Pumps - Antagonists & Inhibitors
dc.subject.meshPyrazoles - Adverse Effects - Therapeutic Use
dc.subject.meshRecurrence - Prevention & Control
dc.subject.meshRisk Factors
dc.subject.meshSulfonamides - Adverse Effects - Therapeutic Use
dc.subject.meshTreatment Outcome
dc.titleCombination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial
dc.typeArticle
Author Affiliations
  1. United Christian Hospital Hong Kong
  2. Chinese University of Hong Kong